MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-21 for XOMED-TREACE 70-60100 manufactured by Xomed-treace.
[11547]
The patient was intubated under direct vision easily. However, the anesthesiologist was unable to ventilate the patient and so, concerned about tube position, removed the tube and reintubated the patient. Still unable to ventilate, the tube was removed and examined while mask ventilation was continued. At that point it was noted that the plastic adapter was not patent, i. E. , it was impossible to ventilate through the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 18881 |
| MDR Report Key | 18881 |
| Date Received | 1994-09-21 |
| Date of Report | 1994-01-26 |
| Date of Event | 1994-01-19 |
| Date Facility Aware | 1994-01-19 |
| Report Date | 1994-01-26 |
| Date Reported to Mfgr | 1994-01-26 |
| Date Added to Maude | 1995-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XOMED-TREACE |
| Generic Name | LASER SHIELD ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 1994-09-21 |
| Catalog Number | 70-60100 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18808 |
| Manufacturer | XOMED-TREACE |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE N JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-21 |